Ex Parte GLASSMAN et al - Page 13




            Appeal No. 1997-1842                                                                              
            Application 08/068,878                                                                            



                   26.  During the double-blind period, the improvement in all the variables was              
            sustained in the terazosin group but not in the placebo group.  In the placebo group,             
            all the variables reverted back to baseline values (before treatment with terazosin) at           
            the end of the double-blind period.   Fabricius, page 88, first full paragraph, Figures           
            1 through 5.                                                                                      
                   27.  Fabricius concluded that terazosin had been shown to be effective and safe            
            in relieving the symptoms of BPH.  In particular, terazosin was shown to be effective in          
            increasing urine flow rates and decreasing residual urine volume when administered                
            once a day.  Fabricius, page 92, last paragraph.                                                  
                   We conclude, on the basis of findings 11, 12, 15, 16, 19, 20, 24 and 25, that              
            the treatment period of terazosin is a result-effective variable, and variation of the            
            period of treatment would be well within the skill of the ordinary worker in the art.  See        
            In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980).                                   
                   Based on finding 26, the person having ordinary skill in the art would have readily        
            understood that it is desirable to continue treating patients with symptomatic BPH with           
            terazosin for as long as the symptoms persist.  As illustrated in finding 5, without the          
            surgical removal of the prostate adenoma, the urinary symptoms of BPH persist for at              
            least three years.  On the other hand, findings 24-26 establish that halting terazosin            
            treatment results in the reoccurrence of the urinary symptoms of BPH.  Thus, the prior            
            art provides a strong reason, suggestion or motivation to maintain terazosin treatment.           
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